Treating Schizophrenic Smokers: Effects on Craving, Cues and Withdrawal
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This is a clinical research protocol to study the efficacy of combined varenicline (Chantix)
and motivational interviewing (MI) for smoking cessation in a sample of smokers who have been
diagnosed with schizophrenia or schizoaffective disorder. The study is a double-blind,
randomized, controlled, subacute treatment trial of MI plus varenicline (VAR-MI) versus MI
plus placebo (PLA-MI). The pharmaceutical treatment will utilize Chantix at a dose of 1
mg/day for a period of two weeks.
The primary goal is to determine if VAR-MI decreases baseline behavioral measures of urge and
withdrawal and reduces baseline rates of cigarette consumption. The primary efficacy measures
of VAR-MI vs. PLA-MI treatment are: Minnesota Nicotine Withdrawal Scale, Questionnaire for
Smoking Urge-brief, number of cigarettes smoked per day in the previous week, CO levels, and
Brief Psychiatric Rating Scale and Positive And Negative Symptom Scale scores on the last day
of the study. Other primary outcome measures are to determine the effects of VAR-MI and
PLA-MI on smoking cue-induced urges in tobacco cue reactivity sessions and reward
responsiveness as assessed by a computerized task.